Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Unnamed facility
Seoul, South Korea
HbA1c change
Time frame: HbA1c change from baseline to week 12
HbA1c Change
Time frame: HbA1c change from baselint to week 6, 52
FPG
Time frame: FPG change from baseline to week 6,12,52
Glycated albumin
Time frame: Glycated albumin change from baseline to week 6,12,52
Fructosamin
Time frame: Fructosamin change from baseline to week 6,12,52
Waist
Time frame: Waist change from baseline to week 12,52
HbA1c responser (HbA1c<7.0%)
Time frame: HbA1c responser rate at week 12,52
Fasting serum C-peptide
Time frame: Fasting serum C-peptide change from baseline to week 12,52
Fasting Lipid parameters
Time frame: Fasting Lipid parameters change from baseline to week 12,52
Albuminuria
Time frame: Albuminuria change from baseline to week 12,52
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